UCB’s Cimzia gets European nod for rheumatoid arthritis

Shares in Belgian drugmaker UCB were on the rise yesterday as investors celebrated news of a European green light for Cimzia to treat rheumatoid arthritis.

The European Commission has issued its stamp of approval for the drug’s use in combination with methotrexate (MTX) in adult patients with moderate to severe active RA who have failed to respond to treatment with disease-modifying anti-rheumatic drugs, but it has also given the all clear for Cimzia (certolizumab pegol) as a monotherapy in cases where use of MTX is considered inappropriate.

Approval came on the back of solid clinical data from the Rapid 1 and Rapid 2 Phase III trials, which showed that Cimzia – currently the only PEGylated anti-TNF therapy on the market – induced significant improvements in the signs and symptoms of the disease that were sustained for at least two years.

In addition, radiographic data have shown that the drug is able to halt the progression of joint damage associated with the condition and that this effect was sustained for at least 100 weeks as per findings from the open-label extention study of Rapid 1.

Commenting on Cimzia’s approval, Dr Professor Iris Loew-Friedrich, Chief Medical Officer of UCB, stressed that as the drug has been shown to “rapidly reduce the rate of progression of joint damage and to improve measurements of patients' physical function”, areas of a “key concern” for rheumatologists when treating patients with active RA, the firm believes it provides “an important new treatment option” for managing the disease.

New syringe designIn addition to its efficacy, Cimzia, which is administered via subcutaneous injection, also brings the advantage of a new pre-filled syringe designed by UCB in partnership with OXO Good Grips, designed for different grip styles and strengths and, according to the firm, providing “measurable improvements” in the patient experience.

This, the company will no doubt be hoping, could help the product gain some ground on the three anti-TNF big boys on the market - Johnson & Johnson/Schering-Plough's Remicade (infliximab), Abbott Laboratories' Humira (adalimumab) and Amgen and Wyeth's Enbrel (etanercept).

Cimzia won regulatory approval across the pond for the treatment of RA back in May, fuelling a 20% rise in its shares as investors welcomed the taste of new sales particularly in the wake of potentially hard-hitting patent losses for UCB’s big earners Zyrtec (cetirizine) and Keppra (levetiracetam).